U.S. drug agency to propose rules to rein in opioid manufacturing

WASHINGTON (Reuters) – The U.S. Drug Enforcement Administration on Tuesday unveiled plans to rein in the amount of opioids that can be manufactured by drugmakers in a given year in an effort to combat the deadly opioid epidemic in the United States.

FILE PHOTO: Attorney General Jeff Sessions speaks during a civil rights initiative announcement at the Fair Housing Act 50th Anniversary at the Justice Department in Washington, U.S., April 12, 2018. REUTERS/Yuri Gripas

The DEA’s proposed changes to its regulations over addictive drug manufacturing quotas were formally announced by Attorney General Jeff Sessions in a speech on Tuesday.

“Under this proposed new rule, if DEA believes that a company’s opioids are being diverted for misuse, then they will reduce the amount of opioids that company can make,” Sessions said in prepared remarks.

The new regulatory plan comes after the state of West Virginia sued the DEA in December over its drug quota rules, arguing the agency’s policy wrongfully sets manufacturing quotas based on the amounts of pills that drugmakers expect to sell, not on legitimate medical needs.

That approach, the state argued, has contributed to the growing addiction problem and the illegal diversion of pain medication, while caving to the interests of the drug industry.

“We must end senseless death in West Virginia,” state Attorney General Patrick Morrisey said in a statement. “The reform sought by DEA proves the impact of our lawsuit is still reverberating in Washington and producing real results capable of ending the oversupply of deadly and addictive pain killers that has killed far too many.”

The new DEA proposal calls for the government to take into account the potential for diversion of the drugs or the illegal distribution into illicit channels.

It also would require the DEA to take into account input from important stakeholders, including states and the components of the U.S. Department of Health and Human Services, such as the Food and Drug Administration, the Centers for Disease Control and the Centers for Medicare and Medicaid Services, when setting quotas.

The unveiling of the proposal on Tuesday comes after federal, state and local law enforcement officials in West Virginia announced a crackdown on an opioid trafficking ring in Huntington, an area known as “ground zero” for the epidemic.

West Virginia is among the hardest-hit states in the country’s opioid crisis.

According to the Centers for Disease Control and Prevention, 42,000 people died nationwide from opioid overdoses in 2016, the last year with publicly available data.

Reporting by Sarah N. Lynch; Editing by G Crosse and Bill Trott